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A Novel Digitally Driven Approach for Gummy Smile Solution Using Milled Sub-nasal Stent

A Novel Digitally Driven Approach for Gummy Smile Solution Using Milled Sub-nasal Stent: A Clinical Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06991699
Enrollment
10
Registered
2025-05-28
Start date
2024-02-08
Completion date
2025-04-08
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gummy Smile

Brief summary

The objective of this study is to assess the effectiveness of a Polyether ether ketone (PEEK) stent for management of gummy smile.

Interventions

A CBCT will be performed to assess the anatomy of the subnasal area and plan the position, size, shape and thickness of the PEEK Stent. These data will be transferred to a 3D planning software to generate a digital model. Eventually, the PEEK stents will be milled in a milling machine and sterilized in ethylene oxide before the surgery. Local anesthesia will be administered into the vestibular mucosa along the extension of the anterior maxilla. VISTA technique begins with a vestibular access incision in the midline frenum and 2 bilateral incisions at premolar area. A periosteal elevator will be introduced through the incision and inserted between the bone and periosteum to elevate the tissue, creating a subperiosteal tunnel, extending distally based on the dynamic of the smile. The PEEK stent will be in one piece. They will be placed onto the bone and stabilized with 2 bone graft screw for each side. The midline incision and the lateral incisions will be sutured primarily.

Sponsors

taher helmy ismail metwaly
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Systemically healthy individuals * Chiefs complain gummy smile * Gummy smile due to short hypermobile upper lip * Gingival Display not more than 5 mm

Exclusion criteria

* Pregnancy * Lactation * History of smoking more than 10 cigarettes per day * Systemic conditions or intake of medications that could affect soft and hard tissue healing * Use of orthodontic appliances * Gingival display above 5mm

Design outcomes

Primary

MeasureTime frameDescription
Gingival displayup to 9 monthsDistance from gingival margin to lower border of upper lip vermilion border will be measured

Secondary

MeasureTime frameDescription
Patient satisfactionup to 9 monthsevaluated using a 10-point visual analogue scale (VAS; 0 = not satisfied, 10 = highly satisfied)
Incidence of Postoperative Complicationsup to 9 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026